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Coverage criteria policies

Certolizumab (Cimzia®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Cimzia requires prior authorization from Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Cimzia is generally approved for use in patients diagnosed with moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe Crohn’s disease when all the following criteria are met:

Initial approvals –

  1. Prescribed and followed by Rheumatology, Dermatology or Gastroenterology.
  2. Patient has had a trial and failure of an appropriate regimen of first-line therapy based on the indication for treatment:
    1. Moderate to Severe Rheumatoid Arthritis - DMARD therapy including concurrent use of two or three of the regimens below for at least 3 months or intolerance or a contraindication to use:
      1. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly)
      2. Hydroxychloroquine titrated to 200-400mg daily
      3. Sulfasalazine titrated to 2000mg-3000mg daily
      4. Leflunomide 10-20mg daily

This requirement will be waived for patients presenting with early rheumatoid arthritis and high disease activity and features of poor prognosis (Appendix A).

    1. Psoriatic Arthritis – First line therapy including concurrent use of the regimens below for at least 1 month:
      1. Continuous treatment with a NSAID at therapeutic doses; and,
      2. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly)
    2. Ankylosing spondylitis – Use of first-line therapy including all of the regimens below:
      1. Continuous treatment with a NSAID at therapeutic doses for one month; and,
      2. For patients with only peripheral disease, local corticosteroid injections when the disease process permits; and,
      3. For patients with only peripheral disease, methotrexate 20mg for at least 3 months or Sulfasalazine titrated to 2000mg to 3000mg daily for at least 3 months.
    3. Moderate to Severe Crohn’s Disease – Use of first-line therapy including one of the following:
      1. Treatment with any of the following corticosteroid regimens for two weeks has been ineffective or is contraindicated:
        1. Prednisone 40-60 mg daily
        2. Oral budesonide 9 mg daily
        3. Budesonide rectal; or
      2. Inability to taper off one of the corticosteroid regimens above; or
      3. Breakthrough disease while stabilized for at least 3 months on one of the following therapies:
        1. Azathioprine 2-3 mg/kg daily
        2. 6-mercaptopurine 1-1.5 mg/kg daily
        3. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly)

    This requirement will be waived for patients presenting with fistulizing and severe disease (Appendix B) that were started directly on a biologic.

  1. Patient has had at least a 3-month trial and failure, or intolerance or a contraindication to use, of:
    1. For self-administered therapies: two preferred biologic therapies (Enbrel and Humira).
    2. For professionally administered therapies: two preferred anti-TNF agents, one of which must be Remicade or Simponi Aria. Preferred agents include Remicade, Simponi Aria, Enbrel and Humira.
  2. For psoriatic arthritis, the patient has had a trial and failure of ustekinumab for at least 3 months.
  3. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Additional initial approval criteria for ALL indications

  1. The prescribed regimen is within the FDA-approved dosing regimen.

    Indication

    FDA-approved Regimen

    Rheumatoid Arthritis

    Psoriatic Arthritis

    Ankylosing Spondylitis

    400mg at weeks 0, 2, 4. Follow with 200mg every other week or 400mg every 4 weeks

    Crohn’s Disease

    400mg at weeks 0, 2, 4. If response occurs, follow with 400mg every 4 weeks

  1. No other biologic agent will be used concurrently to treat this indication.

Authorizations will be provided for one year with the following limitations:

  • If used monthly, a maximum of 15 infusions will be approved during the first year and 13 infusions will be approved in subsequent years. If used every other week for rheumatologic conditions, a maximum of 30 infusions will be approved during the first year and 26 infusions will be approved in subsequent years. No more than 1 vial may be billed for each infusion event after the second month of therapy.

Reauthorizations for biologic regimens of up to FDA-approved doses and frequencies

Renewals will be provided annually with provider attestation that they have seen the patient within the last fourteen months and the patient is benefiting from use of the medication.

Requests for more intense (dose or interval) biologic therapy than the FDA-approved regimen

All requests for regimens exceeding the FDA-approved regimen (including annual renewals) will require provider attestation that the off-label regimen is medically necessary.

Definitions

Certolizumab (Cimzia) is a TNF (tumor necrosis factor) blocker indicated for:

  • Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Treatment of adults with moderately to severely active rheumatoid arthritis
  • Treatment of adult patients with active psoriatic arthritis
  • Treatment of adults with active ankylosing spondylitis

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPC Codes:

Codes

Description

J0717

Injection, certolizumab pegol, 1 mg

NDC Codes:

Codes

Description

50474070062

Cimzia 2 x 200 mg kit

50474071079

Cimzia Prefilled 2 x 200 mg/mL kit

50474071081

Cimzia Starter 6 x 200 mg/mL kit

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Cimzia Full Prescribing Information; UCB, Inc., Smyrna, GA; Revised April 2016
  2. Smolen JS, Landewe R, Breedveld FC et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69(6):964-975.
  3. Singh JA, Furst DE, Bharat A, et al., 2012 Update of the 2008 ACR Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care Research 2012:64(5):625-639
  4. Braun J, Berg R, Baraliakos X, et al., 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70:896-904.
  5. Menter A, Korman NJ, Elmets CA, et al., Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol 2011;65:137-74.
  6. Lichtenstein GR, Hanauer SB, Sandborn WJ, et al., Management of crohn’s disease in adults. Am J Gastroenterol 2009; 104:465-483.

Appendix A. American College of Rheumatology guideline criteria for Early RA with Poor Prognosis

Features of Poor Prognosis

Functional limitation (e.g., Health Assessment Questionnaire score or similar valid tools)

Extraarticular disease (e.g., presence of rheumatoid nodules, RA vasculitis, Felty’s syndrome)

Positive rheumatoid factor or anti-cyclic citullinated pieptide antibodies (33-37)

Bony erosions by radiograph

Criteria based on 2012 Update of the 2008 ACR Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis

Appendix B. American College of Gastroenterology guideline criteria for Severe Crohn’s Disease

Features of Severe Crohn’s Disease (usually corresponding to CDAI > 450)

High Fever

Persistent Vomiting

Evidence of Intestinal Obstruction

Significant Peritoneal Signs - involuntary guarding and rebound tenderness, cachexia or evidence of abscess

Criteria based on 2009 ACG Practice Guidelines for Management of Crohn’s Disease in Adults

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Policy activity

  • 11/20/2008 - Date of origin
  • 07/01/2017 - Effective date
Review date
  • 08/2017
Revision date
  • 10/01/2016

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